A5.4 A survey to explore the programmatic feasibility of levofloxacin (Lfx) TPT for MDR-TB contacts11

Introduction

The survey assessed the feasibility of programmatic use of Lfx for TPT among contacts of MDR-TB patients in the eventuality of a WHO recommendation for its programmatic use. The objective was to collect perspectives from national TB programmes (NTPs), explore current practices for MDR TPT, its programmatic feasibility, affordability, impact on equity, acceptability to patients and health-care workers and to inform the discussion of WHO Guideline group at its meeting on 4–6December 2023.

Methods

Sampling and recruitment strategy: Purposive sampling of NTP managers in 30 countries listed by the WHO as having the highest burden of MDR-TB who were contacted from publicly listed e-mail addresses. 18 programme managers responded within the expected timeline, comprising three in the WHO African Region, two in the South-East Asia Region, seven in the European Region, one in the Eastern Mediterranean Region, and five in the Western Pacific Region. The perspectives of NTP managers were collected on a self-administered, short-answer survey questionnaire sent by e-mail.

Results

Current practice in use of MDR TPT among contacts of DR/MDR-TB patients: Seven (39%) of 18 NTP managers reported use of 6Lfx for MDR-TB contacts, although in two countries use was limited due to high background resistance to FQs. One respondent each reported use of 9-month Lfx as a part of a two-drug regimen with either ethionamide or prothionamide as a companion drug, high-dose INH and either 6-month standard dose INH or 3 months of once-weekly INH and rifapentine. Three (17%) did not specify the TPT regimen being used. Eight (44%) respondents reported no use of TPT for contacts of DR/MDR-TB patients.

Affordability: Respondents were informed about the estimated cost of providing 6Lfx at the Global Drug Facility price per treatment course (approximately US$ 18.50, as compared with 6H at US$ 3.50 and 9H at US$ 5.25). Most respondents considered 6Lfx to be affordable. Nine (50%) stated that it would be affordable for all ages, three (17%) that it would be affordable only for HHCs < 15 years and one (6%) only for HHCs < 5 years. Three (17%) respondents stated that 6Lfx would not be affordable and two (11%) that it would depend on the availability of donor funding.

Programmatic feasibility (additional resources required, distribution, training, timeline): Nine (50%) of the 18 respondents suggested that the cost and the availability of additional resources would not be barriers to implementation, while seven (39%) considered that additional funding would be necessary for expansion of drug-susceptibility testing, contact screening, monitoring and follow-up for individuals started on TPT. Five (28%) respondents noted that implementation of 6Lfx TPT would divert resources from other services and called for proactive planning. All the managers stated that logistics management for Lfx would be sustainable. Nine (50%) managers stated that no training or < 12 h of additional training would be required for health-care workers, and four (22%) respondents said that > 12 h of training would be necessary.

With regards to the timeline for nationwide scaling up of 6Lfx TPT, nine (50%) respondents estimated that it would take <3 years and one (6%) stated >3 years. The others either did not provide information or were unsure. Acceptability to health-care workers was generally anticipated to be high, five (28%) respondents expected health-care workers to remain neutral, some expressed concern about fear of Lfx resistance by health-care workers and that TPT uptake remains low among contacts of drug susceptible TB patients. Acceptability among recipients was also anticipated to be relatively high given the severity of MDR-TB disease, stigmatization and resulting socioeconomic challenges. Other challenges may include lack of community awareness, long duration of TPT and potential side-effects.

Equity considerations: NTP managers expected equity to be increased due to prevention of MDR-TB disease, although six (33%) respondents expressed concern about access in remote locations, and two mentioned a risk of drug shortages if computation of requirements is based on notification data. Eleven (61%) respondents also raised concern about increased out-of-pocket spending for contacts, and two (11%) mentioned that health insurance does not cover TB treatment.

Implementation decisions: Seven respondents reported current use of 6Lfx, and eight expressed willingness to implement it immediately or after a few years provided WHO made a strong recommendation. Only two (11%) respondents stated that they would not implement 6Lfx despite a strong recommendation. In the case of a conditional WHO recommendation, seven (39%) respondents stated that programmatic implementation was less likely, while some mentioned slow or staggered implementation or faster introduction in some regions than in others.

Conclusion

Most national programme managers were willing to use 6Lfx for MDR-TB contacts after a strong WHO recommendation. 6Lfx is anticipated to be generally affordable and feasible, would increase equity and would be acceptable to both health-care workers and contacts. Specific concerns of national programme managers were constraints in funding, human and other resources, fear of increased Lfx resistance and increased out-of-pocket spending, which would reduce equity. Although not all countries responded, those that did can be considered reasonably representative. As this was a short cross-sectional, self-administered survey, broader programmatic perspectives of NTP managers about the affordability or feasibility of obtaining additional resources could not be evaluated.

11 Harsimren Sidhu, Dick Menzies (McGill International TB Centre & WHO Collaborating Centre in TB Research, Montreal Chest Institute and Research Institute of McGill University health centre)

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